title: Teratogenic effect of hydroxyethylrutoside, a flavonoid derivate drug--a population-based case-control study.
abstract: OBJECTIVE
  Hydroxyethylrutoside (HER), a flavonoid derivate drug, used frequently in pregnant women for the treatment of vascular diseases. The aim of this case-control study was to evaluate the teratogenic potential of oral HER treatment in the population-based Hungarian Case-Control Surveillance System of Congenital Abnormalities.
  
  
  METHODS
  Comparative analysis of exposure (HER treatment) during pregnancy in the mothers of cases with congenital abnormalities and matched control newborns without any defect in the population-based Hungarian Case-Control Surveillance System of Congenital Abnormalities.
  
  
  RESULTS
  Of the 22,843 cases with congenital abnormalities, 567 (2.5%) had mothers with HER treatment while of 38,151 matched controls, 1143 (3.0%) were born to mothers with HER treatment (OR with 95% CI: 0.8, 0.7-0.9). However, an association of HER treatment during the second and/or third month of pregnancy was found with the higher risk of unilateral ocular coloboma (OR with 95% CI: 5.4, 2.2-12.9) and a new congenital abnormality syndrome including anotia/microtia, poly/syndactyly and caudal (genital and anal) defects (OR with 95% CI: 3.0, 1.3-27.4).
  
  
  CONCLUSIONS
  Oral HER treatment during early pregnancy associates with a higher risk for ocular coloboma and for a newly delineated congenital abnormality syndrome.
authors.affiliation: Foundation for the Community Control of Hereditary Diseases , Budapest , Hungary and.
authors.forename: Eva
authors.initials: E
authors.lastname: Pósfai
authors.forename: Ferenc
authors.initials: F
authors.lastname: Bánhidy
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Czeizel
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000293:Adolescent; D000328:Adult; D016022:Case-Control Studies; D005260:Female; D005419:Flavonoids / Q000633:toxicity*; D006801:Humans; D006814:Hungary / Q000453:epidemiology; D006896:Hydroxyethylrutoside / Q000633:toxicity*; D011247:Pregnancy; D013723:Teratogens / Q000633:toxicity*; D055815:Young Adult
chemical_list: D005419:Flavonoids; D006896:Hydroxyethylrutoside; D013723:Teratogens
keywords: Congenital abnormalities; hydroxyethylrutoside; new congenital abnormality syndrome; ocular coloboma; population-based case–control study; pregnancy